1). Field of the Invention
This invention relates to packaging of catheter products.
2). Discussion of Related Art
Catheter products are increasingly used for gaining entry into internal target sites, for example for gaining entry into a lumen or other vascular of a person, and for passing diagnostic, therapeutic or other agents into or removing fluids from the internal target sites.
A catheter product of this kind usually includes a body, and an elongate vascular access member having a first end secured to the body and a second end located distant from the body. The second end is inserted into a lumen or other vascular. Many catheter products have needles located in their vascular access members, the needles having sharp tips which are used for piercing a required area for purposes of gaining entry. On other catheter products the vascular access members themselves are needles which have second ends which are sharpened for purposes of gaining entry. Once entry is gained into a required internal target site, fluids can be passed through the vascular access member and the body to or from the internal target sites.
A catheter product is usually packaged by first inserting the vascular access member thereof through an opening in a sheath, followed by the body thereof. The body is then secured to the sheath so that the catheter product is located in a stationary position relative to sheath with the second end of the vascular access member located distant from an inner wall of the sheath. The sheath then provides the necessary structure to protect the vascular access member.
Once the catheter product is secured to the sheath, a portion of the body of the catheter product still protrudes from the opening in the sheath, thus potentially exposing the portion of the body protruding from the opening in the sheath to contamination. An interface between the body and the sheath is also usually not of the kind which prevents ingress of contaminants into that the sheath, thus potentially exposing the remainder of the catheter product, including the vascular access member, to contamination.
To prevent contamination, the sheath and the catheter product are subsequently loosely located within conventional blister packaging. The blister packaging provides an enclosure which is sealed against ingress of contaminants and prevents contamination of the sheath and catheter product. The catheter product, in effect, therefore has to be packaged twice, once to provide the required structural integrity to protect the vascular access member, and once more to prevent contamination.